510(k) K091789 ยท DQK Computer, Diagnostic, Programmable
CARTO RMT EP NAVIGATION SYSTEM V8
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Oct 1, 2009 |
| Received | Jun 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091789
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.